Evrysdi™ (risdiplam)
Published March 18, 2021
Summary
CPSC records recall 21729, published March 18, 2021. Recalling firm: Genentech, a member of the Roche Group, of South San Francisco, Calif.; Reported units: About 14,000.
What's the hazard
The bottles containing the prescription drug can leak due to a fit issue between the press-in bottle adapter and bottleneck. If the bottle is leaking, there is a risk of drug exposure by contact with skin or eyes. Prescription drugs must be in child resistant packaging that prevents children from gaining access to the contents as required by the Poison Prevention Packaging Act (PPPA).
What to do
Consumers should immediately store Evrysdi in a safe location out of reach and sight of children. Consumers should inspect the bottle for any leaking. If it is leaking, contact Genentech for a free replacement. Consumers can continue to use as directed, as the leakage is not anticipated to impact the safety or efficacy of administered medicine. If Evrysdi gets on your skin, wash the area with soap and water. If Evrysdi gets in your eyes, rinse your eyes with water. Genentech is contacting all known purchasers directly.
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Recall details
- Brand
- Genentech, a member of the Roche Group, of South San Francisco, Calif.
- Manufacturer
- Genentech, a member of the Roche Group, of South San Francisco, Calif.
- Distributor
- Select specialty pharmacies nationwide as a prescribed medicine from August 2020 through the present. The price of the medication varies based on health insurance terms and other factors.
- Country
- US
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Questions about this recall
Was Evrysdi™ (risdiplam) recalled?
Yes. CPSC published recall 21729 on March 18, 2021. Reported hazard: The bottles containing the prescription drug can leak due to a fit issue between the press-in bottle adapter and bottleneck. If the bottle is leaking, there is a risk of drug exposure by contact with skin or eyes. Prescription drugs must be in child resistant packaging that prevents children from gaining access to the contents as required by the Poison Prevention Packaging Act (PPPA).
What should I do if I have this product?
Consumers should immediately store Evrysdi in a safe location out of reach and sight of children. Consumers should inspect the bottle for any leaking. If it is leaking, contact Genentech for a free replacement. Consumers can continue to use as directed, as the leakage is not anticipated to impact the safety or efficacy of administered medicine. If Evrysdi gets on your skin, wash the area with soap and water. If Evrysdi gets in your eyes, rinse your eyes with water. Genentech is contacting all known purchasers directly.
How do I know if my unit is part of the recall?
Compare your product details with the notice. Brand: Genentech, a member of the Roche Group, of South San Francisco, Calif..